A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers

A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.

Study Overview

• Status: Completed
• Conditions: Healthy; Pharmacokinetics of ASP7991
• Intervention / Treatment: Drug: Placebo; Drug: ASP7991

Detailed Description

This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.

Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kantou, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
• Body weight: ≥50.0 kg, <80.0 kg
• BMI: ≥17.6, <26.4
• Serum corrected calcium concentration: ≥9.0mg/dL, <10.4 mg/dL

Exclusion Criteria:

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
• Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
• Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
• A deviation from normal criteria range of 12-lead ECG (QT evaluation)
• A deviation from the normal range in clinical laboratory tests
• Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
• History of drug allergies
• Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
• Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
• Concurrent or previous endocrine disorders (e.g.,hyperthyroidism, aberration in growth hormone)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part-1 dose 1	Drug: ASP7991; oral
Experimental: Part-1 dose 2	Drug: ASP7991; oral
Experimental: Part-1 dose 3	Drug: ASP7991; oral
Experimental: Part-1 dose 4	Drug: ASP7991; oral
Experimental: Part-1 dose 5	Drug: ASP7991; oral
Experimental: Part-1 dose 6	Drug: ASP7991; oral
Placebo Comparator: Part-1 placebo	Drug: Placebo; oral
Experimental: Part-2 fed	Drug: ASP7991; oral
Experimental: Part-2 fasted	Drug: ASP7991; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs	for 96 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F	Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours	for 96 hours after dosing
Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr	Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours	for 96 hour after dosing
plasma parathyroid hormon concentration	Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours	for 96 hours after dosing

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 30, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: food effect; ASP7991; Plasma concentration; PTH (parathyroid hormone)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcimimetic Agents; ASP7991
• Other Study ID Numbers: 7991-CL-0001